Clinical Research Associate II - Remote
Sunnyvale, CA 94089
Job Description
A biomedical manufacturing company is seeking a Clinical Research Associate who will be primarily responsible for carrying out the responsibilities involved in the execution of IVD clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various stages or phases in the life cycle of the product including alpha (early stage feasibility), beta and most importantly the clinical studies that validate the product.
ESSENTIAL JOB RESPONSIBILITIES:
- Perform internal performance testing such as proficiency and system testing
- Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products
- Identify potential investigators, prepare site budgets and contract agreements
- Collect, review and process regulatory documents and correspondence from participating trial sites
- Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required.
- Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution
- Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
- Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
- Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance
- Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
- For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
Job Requirements
Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.
Knowledge and skills:
Minimum of 3-4 years of experience with In Vitro Diagnostic (IVD) products
Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment
Excellent communication and team skills
Effective interpersonal skills
Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
Experience in the handling and shipping of Bio hazardous specimens.
Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
Knowledge of GCP & ICH guidelines and FDA regulations
Working knowledge of the diagnostic field and clinical trial material that is to be studied
30-50% travel required
PREFERRED REQUIREMENTS:
Good understanding of medical terminology, human physiology and laboratory testing
Knowledge of regulatory and clinical practices (GCP, ICH)
Experience with laboratory automation and biological databases
Previous hands-on experience in clinical research at either a diagnostic company/hospital or laboratory
Knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, and the current gold standard for the diagnosis of disease
Must be detailed oriented, with strong time management and organizational skills
Additional Information
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.